510(k) · Cleared
Recalled · Class II · 2016Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Midas Rex · HBB Motor, Drill, Pneumatic
Cleared on Mar 18, 2002 after a 68-day review. The FDA summary names its predicate without a number. 43 later devices descend from it. It has been recalled 9 times.
- Decided
- Mar 18, 2002
- Review
- 68 days
- Class
- Class II
- Product code
- HBB
- Recalls
- 9
- Predicates
- 0
43 later devices descend from it, 11 citing it directly.
- This deviceK020069 Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High…Medtronic Midas Rex · 2002
- Descendant · cites it directly · 20 of its ownK090112 Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710…Medtronic Powered Surgical Solutions · 2009
- Descendant · cites it directly · 13 of its ownK072315 Midas Rex Curved BurMedtronic Powered Surgical Solutions · 2007
- Descendant · cites it directly · 11 of its ownK170312 IPC systems, Legend EHS handpieces and Legend Stylus Touch…Medtronic Powered Surgical Solutions · 2017
- Descendant · cites it directly · 10 of its ownK163182 Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill…Medtronic Powered Surgical Solutions · 2017
- Descendant · 2 generations on · 9 of its ownK160713 Stealth-Midas SystemMedtronic Powered Surgical Solutions · 2016
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K090112Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700Medtronic Powered Surgical Solutions · 2009 · cites it directly20descendants
- K072315Midas Rex Curved BurMedtronic Powered Surgical Solutions · 2007 · cites it directly13descendants
- K170312IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…Medtronic Powered Surgical Solutions · 2017 · cites it directly11descendants
- K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating…Medtronic Powered Surgical Solutions · 2017 · cites it directly10descendants
- K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions · 2016 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020069 | Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System… | Medtronic Midas Rex | 2002 | — |
| +1 | K090112 | Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710… | Medtronic Powered Surgical Solutions | 2009 | — |
| +1 | K072315 | Midas Rex Curved Bur | Medtronic Powered Surgical Solutions | 2007 | — |
| +1 | K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw… | Medtronic Powered Surgical Solutions | 2017 | — |
| +1 | K163182 | Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System… | Medtronic Powered Surgical Solutions | 2017 | — |
| +2 | K160713 | Stealth-Midas System | Medtronic Powered Surgical Solutions | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HBB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HBB device
- #1 K253772 Velocity Alpha MR High Speed Surgical Drill…score 11.0 · 1 generation · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Midas Rex Classic Named without a submission number | |
| * | — | Midas Rex III Instrumentation System Named without a submission number | |
| * | — | Mednext 1000 Bone Dissecting System Named without a submission number |
What descends from it? (43)
See all 4311 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090112 | Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700 | 2009 | 20 |
| K072315 | Midas Rex Curved Bur | 2007 | 13 |
| K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw… | 2017 | 11 |
| K163182 | Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating… | 2017 | 10 |
| K041754 | Stryker Maestro System | 2004 | 8 |
| K163565 | MR8 Drill System | 2017 | 7 |
| K032607 | Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185 | 2003 | 6 |
| K193630 | hekaDrill | 2021 | 0 |
| K093361 | Synthes Air Pen Drive (Apd) System | 2010 | 0 |
| K042974 | Medicon Vipair High Speed System | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2016 | Class II | Z-1602-2016 | Labeling mix-ups | Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248. |
| Oct 21, 2015 | Class II | Z-0321-2016 | Process control | The wire pass hole is not present on the tools. |
| Nov 30, 2009 | Not classified | Z-0546-2010 | Nonconforming Material/Component | Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use. |
| May 30, 2008 | Not classified | Z-2156-2008 | Process control | Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. This may lead to reduced cutting performance, inability to perform desired dissection, increased risk of overheating, and potential need for… |
| Sep 1, 2005 | Not classified | Z-1574-05 | Other | Potential compromise of sterile packaging for disposable dissecting tools. |
| Jun 29, 2005 | Not classified | Z-1067-05 | Other | Complaints of finger control component breaking off and falling into open surgical wound. |
| Nov 11, 2004 | Not classified | Z-0278-05 | Other | Softer hose increases the propensity for outer exhaust hose to kink or become occluded as a result of clamping. Complaints of hose rupture/burst have been reported. |
| Nov 3, 2004 | Not classified | Z-0213-05 | Other | Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke). |
| Nov 11, 2002 | Not classified | Z-0419-03 | Other | Lubricant leaking from motor after sterilization causing bleed-through sterilization wrap and/or excess lubricant in instrument case. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090112 (Medtronic Powered Surgical Solutions, 2009) has gone furthest, with 20 descendants of its own.
How does its category compare?
All HBB devicesHBB Motor, Drill, Pneumatic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HBB
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · HBB
Too few HBB 510(k)s in any year since 2007 to give a median.
Recalls per year · HBB
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBB
1,016in 2025
MAUDE reports naming product code HBB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 82 |
| 2008 | 0 | — | 1 | 176 |
| 2009 | 1 | — | 1 | 196 |
| 2010 | 2 | — | 0 | 183 |
| 2011 | 0 | — | 0 | 399 |
| 2012 | 0 | — | 0 | 379 |
| 2013 | 0 | — | 1 | 685 |
| 2014 | 0 | — | 0 | 562 |
| 2015 | 1 | — | 1 | 440 |
| 2016 | 0 | — | 0 | 273 |
| 2017 | 1 | — | 1 | 203 |
| 2018 | 1 | — | 0 | 295 |
| 2019 | 0 | — | 0 | 284 |
| 2020 | 0 | — | 0 | 263 |
| 2021 | 0 | — | 0 | 260 |
| 2022 | 0 | — | 0 | 172 |
| 2023 | 0 | — | 0 | 180 |
| 2024 | 0 | — | 0 | 759 |
| 2025 | 0 | — | 2 | 1,016 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Medtronic Midas Rex Legend System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020069 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020069: Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020069
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026